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Completed

NCT Number: NCT00316381

Stem Cell Therapy to Improve Myocardial Function in Patients With Acute Myocardial Infarction

The purpose of the study is to compare the efficiency of a sorted subpopulation of CD34+/CXCR4+ cells and unselected bone marrow-derived progenitor cells in the treatment of patients with acute myocardial infarction and a low left ventricular ejection fraction.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

III Division of Cardiology Silesian School of Medicine, Katowice, Poland

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About this study

Aim is to compare the efficiency of sorted subpopulation of CD34+/CXCR4+ cells and unselected bone-marrow-derived progenitor cells in treatment of patients with acute myocardial infarction and low left ventricular ejection fraction. The subpopulation of CD34+/CXCR4+ cells most likely contains the tissue-specific stem cells likely to be involved in myocardial salvage/regeneration after ischemic injury. This approach is novel and original, because so far no study identified the type of cells that actually contribute to stem cell-induced improvement in myocardial function in patients with AMI which were treated with unselected population of cells. The REGENT trial (prospective, randomized, multicentre trial comparing unselected BM mononuclear cells and sorted CD34/CXCR4+ cells in patients with myocardial infarction and low left ventricular ejection fraction) successfully treated with primary percutaneous coronary angioplasty within 12 hours after the onset of chest pain. The cells are delivered by intracoronary infusion. Efficiency is assessed by cardiac magnetic resonance imaging, echocardiography and left ventricular angiography.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute myocardial infarction treated successfully with primary coronary angioplasty
  • Left ventricular ejection fraction less than 40%
  • Informed consent granted

Exclusion criteria

  • Presence of significant coronary stenoses in non-infarct related artery requiring revascularization
  • Cardiogenic shock
  • Previous myocardial infarction
  • Age < 18 years and > 75 years
  • Pregnancy
  • Neoplasm
  • Contraindications for MRI

Treatment and study plan

Autologous bone marrow-derived stem cells

Procedure

Primary outcomes

  1. Left ventricular ejection fraction and volumes measured by echocardiography

    Time frame: 6 months

  2. Left ventricular ejection fraction and volumes measured by angiography

    Time frame: 6 months

Secondary outcomes

  1. Safety

    Time frame: 6, 12 months

  2. Left ventricular function in dobutamine stress test

    Time frame: 6 months

  3. Coronary flow reserve by adenosine MRI test

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Silesian School of Medicine

Other

Collaborators

  • Ministry of Science and Higher Education, Poland

Registry information

Official study title

Myocardial REGeneration by Intracoronary Infusion of Selected Population of stEm Cells in Acute Myocardial iNfarcTion. Randomized Multicenter Trial

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Apr 20, 2006
Registry last updated
May 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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